This Funding Opportunity Announcement (FOA) encourages
Research Project Grant (R21) applications from institutions/ organizations
that propose to develop non-invasive methods to support outpatient clinical
trials of pharmacotherapies for Substance Use Disorders (SUDs).

Clinical trials evaluating the efficacy of medications to
treat SUDs are limited by two major issues: a) uncertainty in assessing the
level of a subject’s adherence to the trial medication regimen and b) an
inability to accurately and quantitatively monitor the frequency and level of
a subject’s illicit drug exposure). This FOA encourages the development of
systems that address at least one of these issues. Applications submitted to
this opportunity should focus around an outpatient clinical trial, with or
without preclinical system development studies. Applications not
seeking to test a minimally invasive bioassay system in a clinical trial are
not appropriate for this opportunity.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Clinical trials evaluating the efficacy of medications to
treat Substance Use Disorders (SUDs) are limited by two major issues: a) uncertainty
in assessing the level of a subject’s adherence to the trial medication regimen
and b) an inability to accurately and quantitatively monitor the frequency and
level of a subject’s illicit drug exposure. This FOA encourages the development
of systems that address at least one of these issues. Applications responding
to this announcement might aim to conduct in vitro / preclinical development
studies, an outpatient clinical trial to conduct iniktial tests on a
predeveloped technology or a combination of the two study types. Systems that
would be suitable would have employ an analyte appropriate to determine
adherence to a regimen or accurately assess consumption of an illicit drug with
the necessary sensitivity and specificity for the purpose. An appropriate
system would rely on a sampling matrix (eg blood, urine, sweat etc) that is
appropriate to the purpose with regards to invasiveness, analyte stability and
how well the matrix provides a snapshot of drug concentration in the central
compartment at the moment of sampling. Conducting preclinical development
studies as the main aim and forming a Clinical Alliance to conduct an appropriate
initial test of the system / technique / marker in an already approved (ongoing
or concluded) clinical trial would be an effective way to maximise the
potential of an R21 exploratory / development award and therefore is encouraged.

Research Objectives

The first aim of this announcement is to encourage the
development of systems that will improve estimations of level of adherence to
the medication regimen, in a manner that is non / minimally invasive and can be
conducted at "Point of Care". The system should provide a measurement
that is indicative of blood levels of medication / marker at the time the
sample was taken or provide a reasonably precise time at which the medication
was last consumed. An index of overall consumption in the past, such as
provided by hair sampling techniques would not be applicable. Typically such
systems would typically involve two components: a tracer and a detector. The
tracer should require ingestion and could comprise either an agent compounded
with the medication or a component of the medication shell (eg capsule). The
detector should function in a non-invasive manner. This could be by sampling a
biomatrix such as urine, sweat or breath or by detecting some other emission
from the tracer- for example a form of electromagnetic radiation such as radio
waves. Suitable tracer candidates should be chemically stable under standard
storage conditions, be FDA approved for use in humans (or be Generally
Recognized as safe) and lack pharmacological / toxicological effects (at the
proposed dose). Tracers should be low in variability in their rates of rates of
absorption metabolism and elimination. Tracers should not interact with other
drugs, and should not be obscured by food substances or other agents one might
reasonably expect to be present in the population under examination.

The NIDA has recently supported the development and testing
of two new tracers, microdoses of acetazolamide and low doses of quinine.
Applications looking to develop a detector for these tracers (or any others
that fit the criteria) to develop a Point of Care assay would be welcomed. The
NIDA owns no proprietary intellectual property concerning the use of
acetazolamide or quinine as tracers and development under this FOA of detection
systems for their use would be welcomed. Whatever the tracer and detection
system proposed, the system should be able to detect / distinguish the last
time a medication was taken with a window representing at least four dosing
periods (of once or twice per day).

The second aim of this announcement is to encourage the
development of systems that can accurately assess the quantity and frequency of
consumption of an abused drug during an outpatient clinical trial. The current
standard analytical technique in SUD clinical trials is the urine drug test.
This technique can confirm the presence of abused substances but requires a
subject’s visit to the clinic. Furthermore, the proportion and rate at which
different drugs are excreted in urine varies, as does urine volume and the
elapsed time between each void. Because of these factors and the limited number
of data points provided by urinary "spot checks", current urinalysis
techniques lack the precision or n resolution needed to accurately assess changes
in illicit drug exposure over time. Methods relying on subject self-reports of
drug use provide the only current alternative to urinalysis and have been shown
to be unreliable. This FOA seeks to promote the development of systems that can
provide frequent (at least daily) quantitative sampling data of drug
consumption patterns, with subject-identity verification. Proposed solutions
should be able to assess systemic drug levels and be safe, portable, affordable
and simple enough for subjects to take multiple samples at home and return them
for batch analysis. Alternatively, systems that provide a rapid quantitative
read out at point of care would also be of significant value. The system
should depend on non-or minimally-invasive sampling techniques.

The quantitative drug exposure data made available by such
systems could be used during a trial to augment a behavioral paradigm in
maintenance / or improvement of abstinence / use reduction. It would ensure the
accuracy of disorder severity stratification in trial-entry screening and
assignment procedures since poor homogeneity with in a clinical sample
population can profoundly influence trial outcome, especially in small Phase 2
clinical trials. Verification of consumption would aid in post-hoc trial analyses
and the ability to document a therapeutic-induced reduction in illicit drug
consumption would significantly contribute to NIDA’s long-term strategic goal
of validating reduction in illicit drug use as a clinical outcome measure.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National
Institute on Drug Abuse: In light of recent significant advances in rapid
testing for HIV and in effective treatments for HIV, NIDA has revised its 2001
policy on HIV counseling and testing. NIDA-funded researchers are strongly
encouraged to provide and/or refer research subjects to HIV risk reduction
education and education about the benefits of HIV treatment, counseling and
testing, referral to treatment, and other appropriate interventions to prevent
acquisition and transmission of HIV. This policy applies to all NIDA funded
research conducted domestically or internationally. For more information seehttps://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended
Guidelines for the Administration of Drugs to Human Subjects: The National
Advisory Council on Drug Abuse (NACDA) recognizes the importance of research
involving the administration of drugs with abuse potential, and dependence or
addiction liability, to human subjects. Potential applicants are encouraged
to obtain and review these recommendations of Council before submitting an
application that will administer compounds to human subjects. The guidelines
are available on NIDA's Web site at

Points to Consider Regarding Tobacco Industry Funding of
NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages
NIDA and its grantees to consider the points it has set forth with regard to
existing or prospective sponsored research agreements with tobacco companies or
their related entities and the impact of acceptance of tobacco industry funding
on NIDA's credibility and reputation within the scientific community.
Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html)
for details.

Data Harmonization for Substance Abuse and Addiction via the
PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects
studies to employ a common set of tools and resources that will promote the
collection of comparable data across studies and to do so by incorporating the
measures from the Core and Specialty collections, which are available in the
Substance Abuse and Addiction Collection of the PhenX Toolkit
(www.phenxtoolkit.org). Please see NOT-DA-12-008 for further details.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $275,000 in direct
costs over two years with no more than $200,000 in either year.

Award Project Period

The maximum project period is 2 years.

NIH grants policies as described
in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

See Part I. Section III.1 for information regarding the
requirements for obtaining a Dun and Bradstreet Universal Numbering System
(DUNS) Number and for completing and maintaining an active System for Award
Management (SAM) registration. Part I. Overview
Information contains information about Key Dates. Applicants are encouraged
to submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

The R21 exploratory/developmental grant supports
investigation of novel scientific ideas or new model systems, tools, or
technologies that have the potential for significant impact on biomedical or
biobehavioral research. An R21 grant application need not have extensive
background material or preliminary information. Accordingly, reviewers will
focus their evaluation on the conceptual framework, the level of innovation,
and the potential to significantly advance our knowledge or understanding.
Appropriate justification for the proposed work can be provided through
literature citations, data from other sources, or, when available, from
investigator-generated data. Preliminary data are not required for R21
applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an
important problem or a critical barrier to progress in the field? If the aims
of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Are potential problems, alternative strategies,
and benchmarks for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the scientific
goals and research strategy proposed. For additional information on review of
the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: 1) proposed use of the animals, and
species, strains, ages, sex, and numbers to be used; 2) justifications for the
use of animals and for the appropriateness of the species and numbers proposed;
3) adequacy of veterinary care; 4) procedures for limiting discomfort,
distress, pain and injury to that which is unavoidable in the conduct of
scientifically sound research including the use of analgesic, anesthetic, and
tranquilizing drugs and/or comfortable restraining devices; and 5) methods of
euthanasia and reason for selection if not consistent with the AVMA Guidelines
on Euthanasia. For additional information on review of the Vertebrate Animals
section, please refer to the Worksheet for Review of the Vertebrate
Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the
project presents special opportunities for furthering research programs through
the use of unusual talent, resources, populations, or environmental conditions
that exist in other countries and either are not readily available in the
United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center of
Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top half
of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the National Advisory Council on Drug
Abuse. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of applicable
NIH grants and cooperative agreements are required to report to the
Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.